Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Encinitas, California and other locations
Dates
study started
estimated completion

Description

Summary

To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Official Title

A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF PF-06863135, A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH EITHER PF-06801591 OR LENALIDOMIDE IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)

Details

Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This two part study will assess the safety and tolerability of increasing dose levels of PF-06863135 in Part 1, and establish the recommended Phase 2 dose (RP2D) in Part 2.

Keywords

Multiple Myeloma relapse/ refractory multiple myeloma bispecific antibody bispecific BCMA BCMA- CD3 bispecific Phase 1 PF-06863135 PF-06801591 lenalidomide Neoplasms, Plasma Cell PF-06863135 monotherapy IV or SC PF-06863135 + lenalidomide

Eligibility

You can join if…

Open to people ages 18 years and up

  • Relapsed/refractory multiple myeloma
  • Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
  • Performance Status of 0- 2 (unless due to bone pain)
  • Adequate bone marrow, hematological, kidney and liver function
  • Resolved acute effects of any prior therapy to baseline severity
  • Not pregnant

You CAN'T join if...

  • Recent history of other malignancies
  • History of active autoimmune disorders
  • Any form of primary immunodeficiency
  • Active and clinically significant bacterial, fungal, or viral infection
  • Evidence of active mucosal or internal bleeding
  • History of severe immune-mediated adverse event with prior immunomodulatory treatment
  • Major surgery within 4 weeks of study treatment start
  • Radiation therapy within 2 weeks of study treatment start
  • History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
  • Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
  • Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
  • Requirement for systemic immune suppressive medication
  • Current requirement for chronic blood product support

Locations

  • UCSD Medical Center - Encinitas accepting new patients
    Encinitas California 92024 United States
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital) accepting new patients
    La Jolla California 92037 United States
  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UC San Diego Medical Center - Hillcrest accepting new patients
    San Diego California 92103 United States
  • UCSD Medical Center - Vista accepting new patients
    Vista California 92081 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT03269136
Phase
Phase 1
Study Type
Interventional
Last Updated